Newsletter | June 13, 2019

06.13.19 -- Equipment Change Control For GMP Facilities -- How To Get Started

  Small Molecule API Contract Manufacturer Quality Benchmarking (4th Edition)

This market research report provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 22 performance attributes specific to small molecule projects. You can purchase the full report or download a free preview by clicking here.

Featured Editorial
Equipment Change Control For GMP Production Facilities — How To Get Started
By Greg Weilersbacher, Eastlake Quality Consulting

While many in the industry may conceptually understand change control for equipment and facilities, most people lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect. This article is the first in a two-part series providing a detailed framework that can be used by companies in the design of compliant equipment change control procedures.

Key Takeaways From The FDA’s New Continuous Manufacturing Guidance
By Elizabeth Oestreich, Greenleaf Health

The FDA recently issued a draft guidance titled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.

Industry Insights
Flexible Containment Solutions For Safe Handling Of HPAPI Chemical Synthesis
Article | By Scott Patterson, ILC Dover

Flexible containment solutions must work well for every stakeholder. With high potency active pharmaceutical ingredients (HPAPIs) come a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight.

Answering Today’s Pharma Dilemma Of Build Or Buy
Article | By Charles Christy, Lonza Pharma & Biotech

A new business and operating model may address the build or buy dilemma, offering an innovative and agile way to manage demand uncertainty and reduce the risks associated with early investment decisions.

Pre-Hospital Access To Blood: A Trauma Game Changer
Article | By Kevin Lawler, Pelican BioThermal

Administration of blood in the pre-hospital environment is becoming more feasible for emergency helicopter and ground transport crews.

Efficiencies In Powder Dispersion For Manufacturers
White Paper | By Christine Banaszek, Charles Ross and Son Company

Uniformly dispersing powders into a liquid batch in a practical amount of time is a common problem for F&B manufacturers. This white paper explores five tips for dispersing powders more efficiently.

Flexibility And Efficiency In Industrial Automation
White Paper | By Jari Åberg, Elomatic

Insight on building an internal structure that is flexible so that it can be supplemented, if required, according to changing production requirements.

Performance Validation, Verification, Monitoring, And Testing
White Paper | By Rob Rogers, Mettler-Toledo Product Inspection

This white paper gives guidance on the essential processes of validation, verification, and routine performance monitoring for in-line product inspection equipment in food-making facilities.

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies
Q&A | By Aryo A. Nikopour, Nitto Avecia Pharma Services

How to handle extractables and leachables for monocloncal antibodies? The answer to this and related questions come from Nitto Avecia Pharma Services.

Cell Therapy Manufacturing Under GMP - How And When To Get Started
Article | GE Healthcare Life Sciences

Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology, they concurrently evaluate whether to manufacture the therapies on-site. Here is a guideline of how and when to get started.

Implications Of Inaccurate Forecasting On Biologics Manufacturing
Article | Thermo Fisher Scientific

Inaccurate demand forecasts can have significant implications for companies developing biologics. And, it is increasingly difficult to locate capacity to respond to demand changes.

Electronic Lab Notebook Supports Scientific Knowledge Management In R&D
Article | Dassault Systemes Americas

One tool holds a unique position among R&D informatics systems -- electronic laboratory notebooks (ELNs). ELNs both produce data and consume information and are particularly powerful.

Life Science Leader Magazine

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.